Individualizing Treatment for Asthma in Primary Care (Full Study)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age13-75
SponsorDARTNet Institute
About this trial
While asthma therapy is becoming more individualized based on asthma phenotypes, more research is needed to tailor newer therapies to individuals. Inhaled corticosteroid (ICS) medications are the foundation of care for all individuals with persistent asthma. But ICS use is not without possible long term side effects.
This study will compare two currently available approaches to reduce AEX in primary care patients: (1) use of inhaled corticosteroids (ICS) as part of rescue therapy, also known as MART (Maintenance And Reliever Therapy) or PARTICS (Patient Activated Reliever Trigger Inhaled Corticosteriods) therapy - either of these therapies will be called Rescue-Inhaled Corticosteroids or R-ICS pronounced "Ricks," and (2) use of azithromycin (AZ) as a preventive therapy. These treatments will be studied both individually and in combination.
Eligibility criteria
Qualifiers
A clinical asthma diagnosis for at least 1 year;
13-75 years of age;
A prescription for an ICS either used regularly, or on an as needed controller, not reliever, schedule - ICS or ICS + LABA or ICS+LABA+LAMA;
A current ACT total score of <20 OR an exacerbation requiring 72 hours or more of systemic steroids or a hospitalization of at least 24 hours > 30 days and < 365 days prior to enrollment;
Disqualifiers
Another family member living in the same household already enrolled in study;
Life expectancy <1 year (operationalized by the question to the patient's asthma care clinician "Would you be surprised if this person died in the next 12 months? If yes - include, if no - exclude);
No ICS prescribed for the individual (does not have to be using the ICS inhaler);
Active treatment for hematological or solid organ cancer other than basal cell or skin squamous cell cancer (if participant is > 12 months out from original therapy and may be on a cancer maintenance drug that is not otherwise contraindicated they are eligible for the study);
Trial design
Treatments tested in this trial
- Inhaled corticosteroid (ICS)
- Azithromycin
- Asthma Symptom Monitoring Web-based Application
Treatment groups
3,200 Participants
are divided into 4 treatment groupsSponsors and collaborators
DARTNet Institute
Lead sponsor
Penn State University
Collaborator
Icahn School of Medicine at Mount Sinai
Collaborator
University of Colorado, Denver
Collaborator
RAND
Collaborator
University of Washington
Collaborator
University of North Carolina
Collaborator
Reliant Medical Group
Collaborator
Kelsey Research Foundation
Collaborator
University of Kansas
Collaborator
University of Missouri-Columbia
Collaborator
John Peter Smith Health Network
Collaborator
Rutgers University
Collaborator
AdventHealth
Collaborator
Wake Forest University Health Sciences
Collaborator
Source ClinicalTrials.gov